Endometrial sampler

ABSTRACT

An endometrial sampler comprises a rigid hollow tube having a sampling end providing a plurality of sampling ports communicating with the interior of the tube, and sleeve means surrounding the tube and slidable with respect to it. The tube provides forward stop means and rearward stop means, and the sleeve means and tube are reciprocable with respect to one another between a sampling position in which the sleeve means exposes at least one sampling port, and a second position in which the sleeve means engages the forward stop means and covers the sampling ports. Cervical stop means engages the cervix and cooperates with the rearward stop means to limit travel of the sampling end to a predetermined distance beyond the cervix. A source of suction may be connected to the tube to draw sample material through the sampling ports.

United States Patent 1 1 Binard et al.-

[ Dec. 11, 1973 ENDOMETRIAL SAMPLER [75] Inventors: William J. Binard; John F. Dye,

both of Barringtomlll.

[73] Assignee: The Kendall Company, Boston,

Mass.

221 Filed: Sept. 29, 1972 211 App]. No.2 293,676

[52] U.S. CL... 128/2 11, 128/278, 128/305, 128/348 51] Int. Cl A61b 10/00 [58] Field of Search '128/2 R, 2 B, 348, 128/305, 276, 350, 278

[56 I References Cited UNITED STATES PATENTS 2,482,622 9/1949 Kahn 128/348 2,822,809 2/1958 Sollmann 128/348 3,336,916 8/1967 Edlich... 128/2 B 3,394,699 7 1968 Koett 128/2 11 FOREIGN PATENTS ORAPPLICATIQNS 1,161,400 3/1958 France' 128/2 B 483,829 2/1970 Switzerland l28/2 B Primary ExaminerAldrich F. Medberry AttorneyMartin Kirkpatrick 57 ABSTRACT An endometrial sampler comprises a rigid hollow tube having a sampling end providing a plurality of sampling ports communicating with the interior of the tube, and sleeve means surrounding the tube and slid able with respect to it. The tube provides forward stop means and rearward stop means, and the sleeve means and tube are reciprocable with respect to one another between a sampling position in which the sleeve means exposes at least one sampling port, and a second position in which the sleeve meansfengages the forward stop means and covers the sampling ports. Cervical stop means engages the cervix and cooperates with the rearward stop means to limit travel of the sampling end to a predetermined distance beyond the cervix. A source of suction may be connected to the tube to draw sample material through the sampling ports.

8 Claims, 5 Drawing Figures PATENTED DEC 1 I I975 sum 1 or 2 PATENIEUnEc 1 1 I975 SHEEI 2 UP 2 mwE \ENDOMETRIAL SAMPLER This invention relates to the sampling or biopsy of the internal uterine lining (endometrium). Endometrial sampling is a diagnostic technique used primarily in the detection of carcinoma and other metaplasias of the endometrial lining. This procedure is not-to be confused with the well-known routine cervical smear, in which a simple scraping of the easily accessible cervical os is performed in the physicians office with the assistance of a speculum (a device for expanding the vaginal vault). The cervical smear involves no dilation or anesthesia. The endometrial biopsy is a more complicated procedure becausethe tissue to be sampled is relatively inaccessible. v

, Until recently, means for accomplishing endometrial biopsy have been limited to dilation and curettage (D&C in which the sample is obtained during a surgical procedure requiring anesthetic or to entry with a uterine sound (dilator). The latter procedure requires heavy analgesic sedation because of the dilatation, and,

employs the sound in conjunction with a brush, spatula or other sampling means. More recently a device has been developed that introduces a saline solution into the uterine cavity and recovers'the solution into a syringe, bringing-loose mucosal cells from the endome trium along with the solution. Use of this device also requires dilatation of the cervix and analgesia; in addition, the recovered material is suspended in-the saline solution and must be separated from it, requiring an additional step in the diagnostic procedure. Furthermore, the irrigation of the uterus by saline solution creates the possibility of flushing abnormal cells into the oviducts, thus contributing to the risk of implantation (seeding). It is an object of the present invention to provide a means for obtaining a sample of the endometrium that can be'used without dilation and without anesthesia.

It is a further object to provide such means that eliminates the risk of spreading abnormal cells to other organs of the patient. It is another object to provide such means that ohtains a direct sample of the endometrial cells, eliminating the step of separating sample cells from the solution in which they are suspended.

Itis another object to provide such means that samples cells from several portions of the endometrium, without contamination by cells from other tissues.

Finally, it is an object to provide endometrium sampling means that is simple in operation, can be employed quickly, routinely as a diagnostic screening procedure, and safely, without risk of perforation of the uterine wall, that is easily employed in aseptic technique, and that is inexpensive and disposable.

The endometrial sampler of the invention comprises a rigid hollow tube having a sampling end providing a plurality of sampling ports communicating with the interior of the tube, and sleeve means surrounding the tube; the tube and sleeve are-slidable with respect to one another. The tube provides forward stop means and rearward stop means, and the sleeve means and tube and reciprocable with respect to one another between a sampling position in which the sleeve means exposes at least one sampling port, and a second position in which the sleeve means engages the forward stop means and covers the sampling ports. Cervical stop means engages the cervix and cooperates with the rearward stop means to limit travel of the sampling end within the uterine cavity.

In preferred embodiments, a portion of the tube adjacent the sampling end and remote from the tip is smoothly curved through an angle of about 40 to conform to the anatomical structure of the patient, and the sleeve means is flexible and conforms to the smoothly curved portion as it is reciprocated. The tube further provides a connector remote from the sampling end for engagement with a source of suction, and suction is applied through the tube to the sampling ports when the sleeve means is in the sampling position, to draw sample tissue through the ports into the tube. The malleable tube may be shaped for introduction into abnormal situations.

Other objects, features and advantages will appear from the following description of a preferred embodiment of the invention, taken togetherwith the attached drawings thereof, in which:

FIG. 1 shows the-endometrial sampler of the invention, partially broken away;

FIG. 2 is an enlarged view of a portion of FIG. 1 with the sleeve means in sampling position; and

FIGS. 3, 4 and 5 illustrate steps in the procedure of obtaining a sample using the sampler of the invention.

Referring now to the drawings, and in particular to FIG. 1, the endometrial sampler 10 of the invention has a disposable plastic syringe 12 with retractable plunger 14. Secured to syringe 12 by connection 15 is a rigid hollow. tube 16 of metal, preferably stainless steel,,of outside diameter of about 0.072 inch (15 gauge standard wall, needle dimension) and insidediameter of about 0.054 inch. The sampling end 18 of tube 16, re-

mote from syringe 12, provides a rounded smooth tip 20 and a plurality of sampling ports 22 each of diameter of about 1/32 inch; Tube 16 is smoothly curved through an angle of about 40 at a point about two inches from tip 20, to provide conformation with anatomical shape and position of the uterus. A flexible sleeve 24 (preferably made of athermoplastic such as polyethylene) closely surrounds tube 16; tube 16 is slidable within sleeve 24. Sleeve 24 is shorter than tube 16 by about 2 inches.- When tube I6 is retracted with respect to sleeve 24, as seen in FIG. 1, the sleeve covers all of sampling ports 22 and its distal end 26 abuts smoothly against tip 20 to provide a smooth closed exterior surface. Engagement of sleeve 24 with tip 20 (serving as forward stop means) limits rearward travel of tube 16 within the sleeve. When tube 16 is fully advanced within sleeve 24, as seen in FIG. 2, proximal end 34 of sleeve 24 abuts against shoulder 17 of connector 15 (serving as rearward stop means) and the sleeve exposes all of sampling ports 22. Engagement of end 34 with shoulder 17 limits forward travel of tube 16.

Approximately one inch from the distal end 26 of sleeve 24 there is provided, rigidly connected to sleeve 24, a slightly tapered collar 28 acting as a cervical stop.

In use, the sampler of the invention is introduced into the cervix 30 (FIG. 3) with sleeve 24 and syringe plunger 14 in the positions shown in FIG. 1., The sampler is advanced into the uterus with sleeve 24 in the forward position until collar 28 rests against the cervix. Since sleeve 24 covers sampling ports 22 during this part of the procedure, no cells can be introduced into tube 16 from the cervix. Tube 16 is then advanced into the uterine cavity 32 (FIG. 4) through sleeve 24 until as many sampling ports 22 are exposed as desired (FIG. 4). The number of ports exposed may vary according to the dimension of the uterus being sampled. The ultimate extent of penetration into uterine cavity 32 is limited by cervical stop 28 on sleeve 24 in cooperation with shoulder 17 on connector 15, which engages proximal'end 34 of sleeve 24, thus preventing perforation of the uterine wall. Perforation is further prevented by rounded tip 20. Cervical stop 28 additionally serves in conjunction with proximal end 34 as a means for indicating depth of penetration to the operator.

Plunger 14-of syringe 12 is then withdrawn, creating suction through tube 16, and drawing a portion of the contents of uterine cavity 32 through ports 22 into end 18 of tube 16. Suction is continued in order to draw portions of the surface of the intact endometrium 33 into sampling ports 22. Tube 16 may further be rotated slightly during this procedure to ensure sampling of different portions of the uterine cavity.

Holding sleeve 24 and collar 28 in position (FIG. the physician withdraws tube 16, detaching small portions of endometrium 33 which have been drawn into tube 16 through sampling ports 22. End 18 of tube 16 is completely withdrawn into sleeve 24 before sleeve 24 is withdrawn from cervix 30; thus no cervical or other cells can be taken in through ports 22 to contaminate the endometrial sample.

When the entire sampler has been withdrawn, the sampled cells are easily ejected from tube 16 by slight positive pressure exerted through syringe 12.

Suction and pressure may be provided by alternative means such as a pump or bulb aspirator rather than by the syringe, if preferred.

What is claimed is:

l. Endometrial sampler comprising a rigid hollow tube having a sampling end providing a plurality of sampling ports communicating with the interior of said tube and sleeve means surrounding said tube and slidable with respect to it said tube having a distal stop means said sleeve means and tube being reciprocable with respect to one another between a sampling position in which said sleeve means exposes at least one said sampling port, and a second position in which said sleeve means engages said distal stop means and covers said sampling ports.

2. The endometrial sampler tube of claim 1 further providing rearward stop means and cervical stop means on said sleeve for engaging the cervix of a patient, said cervical stop means cooperating with said rearward stop means to limit travel of said sampling'end beyond said cervix.

3. Endometrial sampler comprising a rigid hollow tube having a stop means on its proximal end and a distal sampling end having a closed tip of larger outer diameter than said tube and a plurality of sampling ports communicating with the interior of said tube sleeve means surrounding said tube and slidable with respect to it, said sleeve means being shorter than the length of said tube between said tip and said stop means and of an outer diameter approximately equal to that of said tip said sleeve means and said tube being reciprocable with respect to one another between a sampling position in which said sleeve means exposes at least one said sampling port, and a second position in 5 which said sleeve means engages said tip and covers said sampling ports.

4. The endometrial sampler of claim 3 in which said sleeve means further provides sleeve stop means and cervical stop means for engaging the cervix of a patient, said cervical stop means cooperating with said sleeve stop means to limit travel of said sampling end.

5. The endometrial sampler of claim 4 in which said tube further provides a connector remote from said sampling end, said connector being engageable with a source of suction.

6. In combination with a source of suction, an endometrial sampler comprising a rigid hollow tube having a connector for engagement with said source of suction a sampling end remote from said connector and providing a closed tip of larger outer diameter than said tube end a plurality of sampling ports communicating with the interior of said tube sleeve stop means remote from said sampling end a portion of said tube adjacent said sampling end and remote from said tip being smoothly curved through an acute angle and flexible sleeve means surrounding said tube and slidable with respect to it, said sleeve means being shorter than the length of said tube between said tip and said sleeve stop means and of outer diameter approximately equal to that of said tip said sleeve means and said tube being reciprocable with respect to one another between a sampling position in which said sleeve means exposes at least one said sampling port, and a second position in which said sleeve means engages said tip and seals said sampling ports, said sleeve means conforming to said smoothly curved portion during reciprocation,

said sleeve means further providing cervical stop means for engaging the cervix of a patient, said cervical stop means cooperating with said sleeve stop means to limit travel of said sampling end.

7. In combination with a source of suction, an endometrial sampler comprising a rigid hollow metal tube of outer diameter of about 0.07 inch and inner diameter of about 0.05 inch, and having a connector end engageable with said source of suction a sampling end remote from said connector end providing a smoothly rounded closed tip of outer diameter of about 0.10 inch, and a plurality of sampling ports communicating with the interior of said tube a portion of said tube adjacent said sampling end and remote from said tip being smoothly curved through an angle of about 40 and flexible sleeve means surrounding said tube and slidable with respect to it,

said connector end providing a shoulder engageable with said sleeve means which said sleeve means engages said tip and seals said sampling ports, said sleeve means conforming to said smoothly curved portion during reciprocation,

said sleeve means further providing rigidly connected cervical stop means for engaging the cervix of a patient, said cervical stop means cooperating with said shoulder to limit travel of said sampling end.

v UNl'.|.ED S'I ATES PA'IEN'II OFFICE CERTIFICATE OF CORRECTION Patent No. 3,777,7 43; Dated Bac ll, 1973 William J. Binard and John F. Dye

Inventor(s) It is certified that error appears in the above-identified patent and that saidletters Patent are hereby corrected as shown below:

Aftef claim 7 add the following claim:

--8. The sampler of claim 1, wherein said tube is 'malleable for shaping to anatomical conformation.

Signed and sealed this 27th day of August 1974 (SEAL) Attest:

MCCOY M. GIBSON, JR. I c. MARSHALL'VDANN Attesting Officer Commissioner of Patents FORM era-1050 (IO-69) 

1. Endometrial sampler comprising a rigid hollow tube having a sampling end providing a plurality of sampling ports communicating with the interior of said tube and sleeve means surrounding said tube and slidable with respect to it said tube having a distal stop means said sleeve means and tube being reciprocable with respect to one another between a sampling position in which said sleeve means exposes at least one said sampling port, and a second position in which said sleeve means engages said distal stop means and covers said sampling ports.
 2. The endometrial sampler tube of claim 1 further providing rearward stop means and cervical stop means on said sleeve for engaging the cervix of a patient, said cervical stop means cooperating with said rearward stop means to limit travel of said sampling end beyond said cervix.
 3. Endometrial sampler comprising a rigid hollow tube having a stop means on its proximal end and a distal sampling end having a closed tip of larger outer diameter than said tube and a plurality of sampling ports communicating with the interior of said tube sleeve means surrounding said tube and slidable with respect to it, said sleeve means being shorter than the length of said tube between said tip and said stop means and of an outer diameter approximately equal to that of said tip said sleeve means and said tube being reciprocable with respect to one another between a sampling position in which said sleeve means exposes at least one said sampling port, and a second position in which said sleeve means engages said tip and covers said sampling ports.
 4. The endometrial sampler of claim 3 in which said sleeve means further provides sleeve stop means and cervical stop means for engaging the cervix of a patient, said cervical stop means cooperating with said sleeve stop means to limit travel of said sampling end.
 5. The endometrial sampler of claim 4 in which said tube further provides a connector remote from said sampling end, said connector being engageable with a source of suction.
 6. In combination with a source of suction, an endo-metrial sampler comprising a rigid hollow tube having a connector for engagement with said source of suction a sampling end remote from said connector and providing a closed tip of larger outer diameter than said tube end a plurality of sampling ports communicating with the interior of said tube sleeve stop means remote from said sampling end a portion of said tube adjacent said sampling end and remote from said tip being smoothly curved through an acute angle and flexible sleeve means surrounding said tube and slidable with respect to it, said sleeve means being shorter than the length of said tube between said tip and said sleeve stop means and of outer diameter approximately equal to that of said tip said sleeve means and said tube being reciprocable with respect to one another between a sampling position in which said sleeve means exposes at least one said sampling port, and a second position in which said sleeve means engages said tip and seals said sampling ports, said sleeve means conforming to said smoothly curved portion during reciprocation, said sleeve means further providing cervical stop means for engaging the cervix of a patient, said cervical stop means cooperating with said sleeve stop means to limit travel of said sampling end.
 7. In combination with a source of suction, an endometrial sampler comprising a rigid hollow metal tube of outer diameter of about 0.07 inch and inner diameter of about 0.05 inch, and having a connector end engageable with said source of suction a sampling end remote from said connector end providing a smoothly rounded closed tip of outer diameter of about 0.10 inch, and a plurality of sampling ports communicating with the interior of said tube a portion of said tube adjacent said sampling end and remote from said tip being smoothly curved through an angle of about 40* and flexible sleeve means surrounding said tube and slidable with respect to it, said connector end providing a shoulder engageable with said sleeve means said sleeve means being shorter than the length of said tube between said tip and said shoulder and of outer diameter approximately equal to that of said tip said sleeve means and said tube being reciprocable with respect to one another between a sampling position in which said sleeve means exposes at least one said sampling port for the application of suction through said tube, and a second position in which said sleeve means engages said tip and seals said sampling ports, said sleeve means conforming to said smoothly curved portion during reciprocation, said sleeve means further providing rigidly connected cervical stop means for engaging the cervix of a patient, said cervical stop means cooperating with said shoulder to limit travel of said sampling end.
 8. The sampler of claim 1, wherein said tube is malleable for shaping to anatomical conformation. 